The development of cirrhosis is the end consequence of all chronic liver disease and represents an important clinical landmark. With development of cirrhosis, one can anticipate decompensation accompanied by esophageal varices, ascites and hepatic encephalopathy and an increased incidence of hepatocellular carcinoma. All these factors determine treatment guidelines including the conditions for screening, vaccination, and liver transplantation referral. It also impacts clinical decision making including surgical risk assessments and medication choices. Thus, making the diagnosis is paramount. At the present time, a liver biopsy is the gold standard. However, it entails a small but significant risk of morbidity and mortality. Pain is the most common complaint and has been reported to be as high as 84%. Bleeding is estimated to occur in 0.1 to 2% and death has been reported to occur in approximately 0.1% of cases. In addition to these inherent risks, there is also concern for sampling error since each biopsy represents only 1/50,000 of the liver and geographic distribution of cirrhosis is not uniform. Further compounding the problem is a 10-20% intra-observer discrepancy among pathologists. These limitations have prompted significant efforts in developing noninvasive techniques for the detection of fibrosis and cirrhosis.
Therefore, it is desirable to develop noninvasive techniques for detecting and diagnosing liver disease, including cirrhosis. This section provides background information related to the present disclosure which is not necessarily prior art.